Status:
COMPLETED
Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-39 years
Phase:
PHASE4
Brief Summary
The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate \[equ...
Detailed Description
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on...
Eligibility Criteria
Inclusion
- Subjects with mild to moderate acne vulgaris on the face,.
- Subjects of either sex aged between 12 and 39 years, inclusive.
- Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.
Exclusion
- Women who are pregnant, breast-feeding, or sexually active with the potential to have children, and not using a contraception method that is safe from a medical point of view
- Subjects using anti-androgen containing contraceptives.
- Subjects who, during the past month, have received oral or topical steroids or antibiotics, or acne treatment of any type, including natural or artificial UV therapy.
- Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal products which will be used during the study.
- Subjects using, or having used in the past month, any significant concomitant medicinal product which might affect their acne, as judged by the Investigator.
- Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
- Subjects with a history of photosensitivity.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00807014
Start Date
November 1 2006
End Date
August 1 2008
Last Update
March 20 2012
Active Locations (8)
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1
Hospital Abente y Lago in La Coruna
A Coruña, Spain
2
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
3
Hospital del Mar
Barcelona, Spain, 08003
4
Hospital Universitario Ramón and Cajal
Madrid, Spain, 28034